NCT03393689

RGD PET/MRI in Sporadic Vestibular Schwannoma

Kan tumorvækst Forudsiges Ved RGD-PET/MR af Vestibularis Schwannomer?

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Rigshospitalet, Denmark · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

The aim of this non-randomised, prospective study is to investigate the applicability and prognostic value of angiogenesis PET/MR with the radioligand 68Ga-NODAGA- E\[c(RGDyK)\]2 in patients with sporadic Vestibuarl Schwannomas.

Detailed description

The radioligand 68Ga-NODAGA- E\[c(RGDyK)\]2 targets the Arg-Gly-Asp (RGD) sequence known to bind with the αvβ3 integrin that is expressed on the surface of angiogenic blood vessels or tumor cells. The radioligand can be used to visualize tumor angiogenesis using PET/MR. A total of 40 patients diagnosed with sporadic vestibular schwannomas will be subjected to an angiogenesis-PET/MR scan. Follow-up MR-only scan will be performed (from the time of the angiogenesis PET/MR) minimum 2 months later in regards to calculate growth rate. The uptake of 68Ga-NODAGA-E\[c(RGDyK)\]2 (Standardized Uptake Values, SUVmax) in tumor lesions will be quantified as Standardized Uptake Values (SUVmax/SUVmean) and compared with PFS, DSS and OS (dichotomized above/below median SUVmax and analyzed by Kaplan-Meier).

Conditions

• Acoustic Neuroma

Interventions

Type	Name	Description
DRUG	One injection of 68Ga-NODAGA-E[c(RGDyK)]2	One injection of 68Ga-NODAGA-E\[c(RGDyK)\]2

Timeline

• Start date: 2018-01-02
• Primary completion: 2021-01-02
• Completion: 2021-01-02
• First posted: 2018-01-08
• Last updated: 2018-01-10

Locations

1 site across 1 country: Denmark